Surgical Tissue Flap for Glioblastoma

Overseen By John Boockvar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Active infection, Other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new surgical technique for individuals with glioblastoma, an aggressive brain cancer. After removing the cancerous tissue, the researchers place a piece of the patient’s own tissue (a surgical tissue flap) in the area where the tumor was, to determine if it helps prevent rapid recurrence. The trial aims to assess whether this method is safe and could extend the period patients live without cancer regrowth. Individuals newly diagnosed with glioblastoma who plan to undergo tumor removal surgery might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this surgical technique is safe for glioblastoma patients?

Research has shown that using a surgical tissue flap to treat glioblastoma appears safe. In a small initial study, doctors placed a piece of the patient's own tissue, known as the temporoparietal fascial (TPF) flap or pericranial flap, into the brain cavity after tumor removal. This procedure proved safe and feasible, causing no major problems or side effects for the patients involved. So far, patients have tolerated this method well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for glioblastoma, which typically involves surgery, radiation, and chemotherapy, the surgical tissue flap technique uses a patient's own tissue to potentially improve outcomes. This method involves placing a piece of tissue, known as the temporoparietal fascial (TPF) flap or pericranial flap, into the area where the tumor was removed. Researchers are excited because this could enhance healing and provide a protective barrier, potentially reducing recurrence and improving survival rates. The use of autologous tissue may also minimize immune response complications, setting it apart from traditional treatments.

What evidence suggests that this surgical technique is effective for glioblastoma?

Research has shown that using a surgical tissue flap, such as the temporoparietal fascial (TPF) or pericranial flap, might improve outcomes for patients with glioblastoma multiforme (GBM), a type of brain cancer. In this trial, participants will receive a pedicled autologous piece of tissue, either the TPF flap or pericranial flap, into the resection cavity where the tumor was removed. A small initial study suggested that this method is safe and effective in this context. This technique aims to help treatments bypass the blood-brain barrier, which often reduces the effectiveness of traditional therapies. While more research is needed, these findings offer hope that this surgical method could help patients with newly diagnosed GBM live longer without their cancer worsening. ^{1 2 3 5 6}

Who Is on the Research Team?

John Boockvar, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with newly diagnosed GBM who are expected to live at least 6 months and can have an MRI. They must be able to undergo a specific surgery, use birth control if of reproductive potential, sign consent, have a KPS of 70% or more, and meet certain lab criteria. Pregnant women, those already treated for GBM or with active infections or other significant health risks are excluded.

Inclusion Criteria

Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control

It is possible to perform TPFF and/or pericranial flap procedure.

Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted)

Exclusion Criteria

Subject, if female, is pregnant or is breast feeding

Subject has an active infection requiring treatment

You have started chemotherapy or radiation treatment for glioblastoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Standard surgical resection followed by implantation of a TPF or pericranial flap into the resection cavity

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical treatment, including MRI assessments and monitoring for progression-free survival

6 months

Multiple visits (in-person) at 24 hours, 7 days, 30 days, 60 days, 90 days, 180 days

Long-term Follow-up

Participants are monitored for overall survival and long-term safety outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Surgical Tissue Flap

Trial Overview The study tests the safety of using one's own tissue (TPF or pericranial flap) surgically placed into the brain after tumor removal in patients with GBM. The goal is to see if this method is safe and might help extend the time without disease progression.

How Is the Trial Designed?

Group I: Surgical tissue autograft: TPF flap/pericranial flap Experimental Treatment 1 Intervention

Use of a pedicled autologous piece of tissue called the temporoparietal fascial (TPF) flap or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

In a study of 177 glioblastoma patients, only 7.9% developed surgical site infections (SSIs) after craniotomy, indicating that while SSIs are a concern, they are relatively infrequent in this population.

The analysis found no significant risk factors for SSIs, and surprisingly, patients who received early postoperative radiation had a lower incidence of SSIs, suggesting that rapid chemoradiation may be beneficial for optimal oncological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Site Infections in Glioblastoma Patients-A Retrospective Analysis. Scheer, M., Spindler, K., Strauss, C., et al.[2023]

The review of cranial tumor surgeries revealed that complication rates can range from 9% to 40%, with deep venous thromboembolism (DVT) being the most common adverse event, occurring in 3% to 26% of cases.

Implementing standardized safety protocols, such as DVT prophylaxis and intraoperative navigation techniques, could potentially reduce the incidence of adverse events and improve patient outcomes in neurosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in neurosurgical adverse events: intracranial neoplasm surgery. Wong, JM., Panchmatia, JR., Ziewacz, JE., et al.[2012]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38664311/

Results from a first-in-human phase I safety trial to evaluate ... This pilot study suggests that insertion of pedicled autologous TPFF/PCF along a GBM resection cavity is safe and feasible.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05954858

Surgical Tissue Flap to Bypass the Blood Brain Barrier in ... The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly ...

3. clinicaltrial.be clinicaltrial.be/en/details/67641?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Surgical Tissue Flap to Bypass the Blood Brain Barrier in... The investigators aim to prove that this surgical technique is safe in a small human cohort of patients with resected newly diagnosed GBM and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11147875/

Results from a first-in-human phase I safety trial to evaluate ... The efficacy of systemic therapies for glioblastoma (GBM) remains limited due to the constraints of systemic toxicity and blood–brain barrier ( ...

5. withpower.com withpower.com/trial/surgical-tissue-flap-for-glioblastoma-5d11e

Surgical Tissue Flap for Glioblastoma The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875020316533

Vascularized Temporoparietal Fascial Flap: A Novel ... This study demonstrates the feasibility of the TPFF technique to bypass this barrier and help facilitate the goal of improving drug delivery.